Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html. Pfizer-BioNTech COVID-19 Vaccine, Bivalent vials contain a frozen suspension without preservative. << Individuals can consult with their health care provider if they have Moderna COVID-19 Vaccine supplied in a vial with a dark blue cap and a 8 0 obj Click here to view and download this information in a table. A carton of 10 vials may take up to 2 hours to thaw in the refrigerator[2C to 8C (35F to 46F)]. WHERE CAN I REPORT CASES OF SUSPECTED FRAUD? The vaccine expires on the last day of the 12th month. >> Adverse reactions following administration of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine or the bivalent vaccine (Original and Omicron BA.1) that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, injection site swelling, fever, injection site redness, lymphadenopathy, nausea, malaise, pain in extremity, rash, and decreased appetite (see Full EUA Prescribing Information). Theres a place for you in the Academy no matter where you are in your career. Department of Health & Human Services. First Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine. Refrigerator: Between 2C and 8C (36F and 46F)A carton of 10 single-dose vials may take up to 2 hours to thaw at this temperature. This will ensure that you receive the same vaccine when you return for the second dose of the primary series. This EUA for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed. The list of vaccines indicated to be WHO-authorized will be updated periodically as the CDC monitors WHO published information. Pfizer says its updated COVID-19 booster significantly revved up adults' virus-fighting antibodies. /MediaBox [0.0 7.9200063 612.0 799.92] endobj Provide a detailed report of vaccine administration error and/or adverse event. 2.0C to 8.0C. 709 0 obj <>stream If the recipient has never received a COVID-19 vaccine, administer 1 dose of Pfizer-BioNTech COVID-19 Vaccine. If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. The manufacture date is printed on the vial (gray cap). Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). << After first puncture, the multiple dose vial should be held between 2C to 25C (35F to 77F). /Pages 2 0 R All information these cookies collect is aggregated and therefore anonymous. /Length 20155 To access the most recent Pfizer-BioNTech COVID-19 Vaccine, Bivalent Fact Sheets, please scan the QR code provided below. Pfizer Peds (Orange cap and Gray cap) Tray containing vaccine vials between -90C and -60C Individual vials between 2C and 8C Not recommended Moderna 50C and -15C or 2C and 8C (36F and 46F) for up to 12 cumulative hours, once or multiple times 2C and 25C for up to 12 hours. This Fact Sheet may have been updated. )%$j\sF_'i{\+ The Pfizer-BioNTech's COVID-19 Vaccine (Gray Cap) CANNOT be stored In. Best used for discovery & interchangable words, Recommended to be used in conjunction with other fields, Up-to-Date Info: To find the latest CDC information on this topic go to: Clinical Trial Results and Supporting Data for EUA (18.1). Once punctured, vials can be stored between 2C to 25C (36F to 77F) for up to 12 hours. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%). CDC twenty four seven. Thawed vaccine cannot be refrozen. After 8/31/2022, only bivalent boosters should be administered to ages 12+ years. Seroresponse for a participant was defined as achieving a 4-fold rise in NT50 from baseline (before primary series). /X10 17 0 R The vaccine elicits an immune response to the S antigen, which protects against COVID-19. If received at 2C to 8C, they should be stored at 2C to 8C. The 305 participants greater than 55 years who received a second booster dose with the bivalent vaccine (Original and Omicron BA.1) received it 4.7 to 11.5 months after receiving the first booster dose and had a median follow-up time of 1.7 months up to a data cut-off date of May 16, 2022. Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or https://TIPS.HHS.GOV. >> Use of unapproved Pfizer-BioNTech COVID-19 Vaccine, Bivalent for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met): OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC. Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above. If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your healthcare provider. Ultra Cold -90C to -60C (-130F to -76F)*. We help more people save through partnerships with leading financial institutions and state governments. Pfizer provided 0.9% Sodium chloride Injection USP diluent for use with the PfizerBioNTech COVID-19 vaccine under the name of its subsidiary, Hospira. The vaccine expires on the last day of the 12th month. Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) or moderate to severe asthma, Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension), Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation), Carton of 10 single dose vials: NDC 59267-1404-2, Carton of 10 multiple dose vials: NDC 59267-0304-2, have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart), have a bleeding disorder or are on a blood thinner, are immunocompromised or are on a medicine that affects your immune system, have ever fainted in association with an injection, completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine; or, receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine, had a severe allergic reaction after a previous dose of COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine. These NDCs will not be manufactured. This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent. If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. A comparison of seroresponse rates to the Original strain was descriptive. The The storage, preparation, and administration information in this Prescribing Information apply to the Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in: Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a suspension for injection. COVID-19 vaccine codes and crosswalks are provided in anticipation of potential vaccine availability under an approved Biologics License Application (BLA), Emergency Use Authorization (EUA), or as a potential vaccine submission for EUA (Pre-EUA). Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. /Title (Pfizer-BioNTech's COVID-19 Vaccine \(Gray Cap\) Ages 12+) Refer to thawing and preparation instructions in the panels below. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30 minutes. Single dose vials with gray caps and labels with gray borders are supplied in a carton containing 10 single dose vials. If not previously thawed at 2C to 8C (35F to 46F), allow Pfizer-BioNTech COVID-19 Vaccine, Bivalent single dose vials or multiple dose vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. >> SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 30 mcg/0.3 mL dose, COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted, for intramuscular use. information about this message, please visit this page: Select up to three search categories and corresponding keywords using the fields to the right. For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. Thawed vials can be stored in the refrigerator [2C to 8C (35F to 46F)] for up to 10 weeks prior to use. Multiple dose vials with gray caps and labels with gray borders are supplied in a carton containing 10 multiple dose vials. Pfizer-BioNTech COVID-19 Vaccine, Bivalent is not authorized for use in individuals younger than 5 years of age. In the following analyses of Study 3 in participants 2 through 4 years of age (606 of whom received Pfizer-BioNTech COVID-19 Vaccine and 280 of whom received placebo), 76.6% of participants had at least 30 days of follow-up after Dose 3. << The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 6 months through 11 years of age should not be used interchangeably with COMIRNATY (COVID-19 Vaccine, mRNA). All CVX codes are associated to the new Vaccine Group COVID-19. CPT codes shown are product codes. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION3. FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent which is not an FDA-approved vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. >> Do : NOT. This Full EUA Prescribing Information may have been updated. Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent on the breastfed infant or on milk production/excretion. The Countermeasures Injury Compensation Program. Forexample,if the manufacture date isAugust 2021(8/21), include August as one of the 12 months; the expiration date will be July 2022 (7/31/22). >> >> endobj You can find the latest versions of these browsers at https://browsehappy.com. << We take your privacy seriously. Vials should be discarded 12 hours after dilution.). Bivalent: Gray capped vial with . 14 0 obj /Kids [6 0 R 7 0 R] Procedures should be in place to avoid injury from fainting. In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose of Pfizer-BioNTech COVID-19 Vaccine were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%). In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. Learn how your gifts makes that possible. 4. /X37 35 0 R Each vial must be thawed prior to administration. If the amount of vaccine remaining in a multiple dose vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. This Fact Sheet may have been updated. Up-to-date Information Up-to-Date Info: To find the latest CDC information on this topic go to: https://www.cdc.gov/coronavirus/2019-nCoV/index.html Pfizer-BioNTech COVID Non-US WHO authorized tradenames/identifiers include VAXZEVRIA, AZD1222, ChAdOx1 nCoV-19, COVISHIELD, AstraZeneca COVID-19 Vaccine (Non-US tradenames include VAXZEVRIA, COVISHIELD), EUA 02/27/2021, 1-dose vaccine. To access the most recent Fact Sheets, please scan the QR code provided below. Of these, 1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) participants have been followed for at least 2 months after the second dose. We're 67,000 pediatricians committed to the optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults. It is predominantly a respiratory illness that can affect other organs. Vaccine expires 12 months after the manufacture date. A booster response to the Pfizer-BioNTech COVID-19 Vaccine was demonstrated regardless of the vaccine used for primary vaccination. >> Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.25 mL dosage, for intramuscular use, 100 mcg/0.5 mL for adult 18+ (Same formulation and concentration as EUA product). through 4 years. 654 0 obj <> endobj Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which is supplied in a single dose and multiple dose vial with a gray cap and a label with a gray border, should not be used in individuals 5 through 11 years of age. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. After withdrawing a single 0.3 mL dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent, administer immediately. EUA Fact Sheet for Vaccination Providers (5 through 11 Years), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Orange Cap. *( hKz%a#GSOE).z ^yb7aal^+Rr]JN From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) participant in the Pfizer-BioNTech COVID-19 Vaccine group vs. 0 (0.0%) in the placebo group. Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. /X30 30 0 R In Study 4, a total of 610 participants greater than 55 years of age previously vaccinated with a 2-dose primary series and 1 booster dose of Pfizer-BioNTech COVID-19 Vaccine went on to receive a second booster dose with either Pfizer-BioNTech COVID-19 Vaccine or the bivalent vaccine (Original and Omicron BA.1). The FDA issued its initial Emergency Use Authorization for the Novavax COVID-19 vaccine on Wednesday July 13, 2022. endobj PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- bnt162b2 original and omicron ba.4/ba.5injection, suspensionPfizer Manufacturing Belgium NV, FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS). Monitor Pfizer-BioNTech COVID-19 Vaccine, Bivalent recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html). Ultra-Cold Temperature Freezer-90.0C to -60.0C. Overall in a similar analysis in which 7960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. Participants were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. Effectiveness of a booster dose of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) was based on an assessment of 50% neutralizing antibody titers (NT50) against SARS-CoV-2 (USA_WA1/2020). /ExtGState << Vaccine Storage and Handling Toolkit. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS*, REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS, CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA, Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial with Gray Cap and Label with Gray Border , https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html. stream No. /ViewerPreferences 4 0 R Cardiac Disorders: myocarditis, pericarditis Gastrointestinal Disorders: diarrhea, vomiting Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema) Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm) Nervous System Disorders: syncope. /X20 20 0 R A clinical study with the bivalent vaccine (Original and Omicron BA.1) included 197 individuals 65 years of age and older and their data contribute to the overall assessment of safety and effectiveness of Pfizer-BioNTech COVID-19 Vaccine, Bivalent. No data are available regarding the use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent during pregnancy. /Count 2
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